Method and apparatus for R-F ablation

ABSTRACT

An ablation catheter and a method of performing cardiac ablation. The catheter is provided with a hollow, helical electrode, which is screwed into cardiac tissue at a desired ablation site and connected to a source of R-F electrical energy to ablate the tissue adjacent the electrode. Prior to ablation, a conductive fluid may be injected through the hollow needle, both to provide for cooling of the tissue adjacent the needle and to increase the conductivity of the tissue in the area of the electrode.

This application claims the benefit of the following: U.S. patentapplication, Ser. No. 08/424,681, filed Apr. 18, 1995 (now abandoned)which is a continuation application of U.S. patent application Ser. No.08/113,441, filed Aug. 27, 1993 and now issued as U.S. Pat. No.5,431,649, issued Jul. 11, 1995.

BACKGROUND OF THE INVENTION

This invention relates generally to the field of devices for cardiacsurgery, and more specifically to devices for R-F ablation of cardiactissue.

The present invention is directed toward treatment of tachyarrhythmias,which are heart rhythms in which an chamber or chamber of the heartexhibits an excessively fast rhythm. In particular, the presentinvention is directed toward treatment of tachycardias, which are due tothe presence of ectopic foci within the cardiac tissue or due to thepresence of aberrant condition pathways within the cardiac tissue.

Therapies have been developed for treating tachycardias by destroyingcardiac tissue containing identified ectopic foci or aberrant conductionpathways. A variety of approaches have been taken, including applicationof electrical energy or other forms of energy to destroy the undesiredcardiac tissue. As examples, ablation of cardiac tissue has beenaccomplished by means of radio frequency electrical current, microwaveenergy, heat, electrical pulses, cryothermy, and lasers. At present,ablation using R-F energy is perhaps the most widely practiced in thecontext of ablation procedures that can be carried out by means of acatheter, inserted into the closed heart.

Most R-F ablation catheters employ electrodes which are intended tocontact the endocardium of the heart, or, in some cases as in U.S. Pat.No. 5,083,565, are intended to penetrate the endocardium, and enter themyocardium. In general, R-F ablation catheters are effective to inducesmall lesions in heart tissue including the endocardium and inner layersof myocardium, in the immediate vicinity of the electrode. However, themedical community has expressed a desire for devices which producelarger lesions, to reduce the number of applications of R-F energy(burns) required to effectively ablate the cardiac tissue associatedwith the tachycardia.

R-F ablation causes tissue in contact with the electrode to heat throughresistance of the tissue to the induced electrical current therethrough.The actual extent of heating is somewhat unpredictable. However,temperature tends to rise as the duration and amplitude of the R-Fsignal increase. Heating of the tissue beyond a certain point can causedissection or charring of the tissue, resulting in a high impedancebetween the R-F electrode and the return electrode, which in turn leadsto cessation of the heating process, and, in some cases, sticking of theelectrode to the charred tissue. One response to this phenomenon hasbeen the inclusion of thermocouple within the ablation electrode, inconjunction with feedback control to modulate the R-F signal to maintainthe electrode temperature at a set parameter. One such system isdisclosed in U.S. Pat. No. 5,122,137.

SUMMARY OF THE INVENTION

The present invention is directed toward improving the consistency andefficacy of R-F ablation, and to increase the overall size and extent ofthe lesions induced by R-F ablation. These goals are pursued by means ofan ablation catheter employing a helical electrode intended to bescrewed into the myocardium at the site intended for ablation. Thehelical electrode provides an enlarged surface are as compared torelatively straight or needle-like electrodes for insertion into theendocardium, and also serves to stabilize the location of the catheterduring the application of the R-F signal. In addition, there isessentially no bleeding following removal of the helical electrode, soit can safely be placed in multiple locations for mapping and ablationpurposes.

An additional aspect of the invention in its preferred embodiment is theprovision of a non-toxic, non-arrhythmogenic, conductive solution suchas Ringer's solution to the area of the electrode, before and duringapplication of R-F energy. In its preferred embodiment, the helicalelectrode is hollow, and the conductive solution is applied through oneor more apertures in the electrode. The conductive solution injectedprior to application of the R-F signal is believed to displace blood inthe vicinity of the electrode. Ringer's solution, for example, has amuch higher conductivity than blood (approximately 3-4×) or cardiacmuscle (approximately 7×), overall resistance to the induced electricalcurrent is reduced, which is believed to assist in expanding the size ofthe lesion, by spreading the effective area of application of theelectrical current over a wider area. Application of the conductivesolution during the burn further assists by preventing overheating ofthe tissue, allowing for a prolonged application of the R-F signal,extending beyond the point at which burning or charring would otherwisenormally occur. Both of these factors are believed to contribute to anincrease in the overall size of the lesion produced by application ofR-F energy at a particular location.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a catheter adapted to perform the improvedmethod of R-F ablation, according to the present invention.

FIG. 2 is a cutaway view through the distal end of the catheterillustrated in FIG. 1.

FIGS. 3, 4, and 5 illustrate alternative embodiments of the helicalelectrode of the catheter illustrated in FIGS. 1 and 2.

FIG. 6 illustrates the associated apparatus for administration ofconductive solution before and during application of R-F energy to thehelical electrode.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is a plan view of a catheter specifically designed for performingR-F ablation according to the present invention. The catheter includesan elongated catheter body 10, comprising an insulative outer sheath 12,which may be made of polyurethane, teflon, or other biocompatibleplastic. A hollow, helical electrode 14 is located at the distal end ofthe catheter and is coupled to the distal end of an internal tube,running the length of the catheter. At the proximal end of the cathetera fitting 16 is located, to which luer lock 18 is coupled. Luer lock 18is coupled to the proximal end of the internal tube. A swivel mount 20is mounted to luer lock 18, allowing rotation of the catheter relativeto luer lock 22. Luer lock 22 is intended to be coupled to a source ofconductive fluid such as Ringer's solution, and allows for applicationof the Ringer's solution through the catheter and through electrode 14,while electrode 14 is being screwed into heart tissue. An electricalconnector 24 exits fitting 16, and is coupled to electrode 14, allowingfor the use of electrode 14 to apply R-F energy to heart tissue.Electrode 14 may also be employed for other related functions such asmeasurement of electrograms within the heart and pacing of heart tissueby application of low energy pulses appropriate for cardiac pacing. Inuse, the catheter is advanced to the desired site for ablation, whichpreferably has been previously identified by means of cardiac mapping ina fashion similar to cardiac mapping presently employed with R-Fablation procedures. The catheter may be guided to the desired locationby being passed down a steerable or guidable catheter, for example, asdisclosed in U.S. Pat. No. 5,030,204, issued to Badger et al., or bymeans of a fixed configuration guide catheter, for example in U.S. Pat.No. 5,104,393, issued to Isner, both of which patents are incorporatedherein by reference in their entireties. Alternatively, the catheter maybe advanced to the desired site within a heart by means of a deflectablestylet, as disclosed in PCT Patent Application WO 93/04724, publishedMar. 18, 1993, or a deflectable guidewire as disclosed in U.S. Pat. No.5,060,660, issued to Gambale, et al., both of which patents areincorporated herein by reference in their entireties. When the hollowneedle 14 is located at the desired location it is screwed into hearttissue by rotating the catheter body. A torque cable within the catheterbody provides for 1:1 torque transfer from the proximal end of thecatheter to the hollow needle 14.

When advanced to the desired location, luer lock 22 is coupled to apressurized source of Ringer's solution. An appropriate source isdiscussed in more detail in conjunction with FIG. 6 below. However, forpurposes of the present invention, a source of Ringer's solution capableof delivering 1 cc per minute of solution at atmospheric pressure hasbeen found to be adequate. Delivery of Ringer's solution should beginbefore or at the time at which the electrode 14 is screwed into thetissue to be ablated. In animal experimentation, the inventors havefound that delivery of Ringer's solution for a period of two minutesprior to the delivery of R-F energy assists in producing a larger butstill controlled, regular lesion.

After the electrode has been located, and Ringer's solution has beenadministered for the desired period of time, electrical connector 24 iscoupled to an R-F electrosurgical power source, of the type commerciallyavailable and employed for cutting an electro-coagulation. The presentinventors have employed a Blendtome brand electrosurgical generator,Model No. 755, coagulation setting number 7, cutting setting number 1.At these settings, a prolonged application of R-F energy, e.g., oneminute or so, may be employed to produce a large, controlled lesion.Greater or lesser time periods may be employed, however, time periodsless than 20 seconds may be counter-indicated, as it appears that thecooling effect of the Ringer's solution, in such shorter R-F applicationtimes, may actually decrease the effective size of the lesion.

After R-F ablation, the electrode 14 may be coupled to a cardiacpacemaker, and cardiac pacing energy may be delivered to the lesion sitein an attempt to measure the pacing threshold. Pacing threshold may bemeasured by delivering pacing pulses at differing energy levels, e.g. byaltering pulse amplitude or width, and determining the minimum energylevel effective to cause a depolarization of cardiac tissue. Theinventors believe that the higher the pacing threshold, assuming arelatively homogenous lesion, the greater lesion size. As such, theelectrode 14 can be used to derive a rough estimate of overall lesionsize. The electrode 14 may also be coupled EKG monitoring equipment toassist in determining whether the tachycardia persists and whether thetissue in the vicinity of the electrode is still participating inaberrant conduction or ectopic activity, associated with thetachycardia.

The helical configuration of electrode 14 is believed to be particularlybeneficial in the context of an ablation electrode. Because theelectrode is screwed into and completely located within the hearttissue, out of the bloodstream, application of R-F energy is limited tothe tissue itself. This differs from traditional R-F ablationelectrodes, which simply contact the endocardium, with the result that asubstantial portion of the energy applied is dissipated in the bloodwithin the heart adjacent the electrode site. Moreover, R-F energyapplied to the bloodstream may cause clotting of the blood adjacent theelectrode, and raise the risk of clots breaking loose of the electrode.

The helical electrode also provides a substantially increased surfacearea as compared to the needle-like electrodes proposed in the abovecited Parins patent, and also serves to anchor the catheter reliablyduring application of the R-F energy. In addition, the helical shape ofthe electrode prevents the application of conductive solution throughthe electrode from causing the electrode to be backed out of itsinsertion site due to hydraulic pressure, as might occur if a straight,hollow electrode were employed. The elongated path defined by thehelical electrode also reduces the possibility of leakage of conductivefluid along the needle and out of the heart tissue.

FIG. 2 illustrates a cutaway version through the end of the catheterillustrated in FIG. 1. In this view, it can be seen that helicalelectrode 14 is provided with an internal lumen 26 which is incommunication with the internal lumen of a tube 30. Tube 30 extends tothe proximal end of the catheter and is in full communication with luerlock 18, as discussed above, tube 30 may be fabricated of polyimidetubing or of stainless steel tubing. In the present invention, thestainless steel tubing serves as an additional conductor, couplingelectrode 14 to electrical connector 24 and enhancing the overallconductivity of the catheter. The use of polyimide tubing, whilereducing the overall conductivity of the catheter enhances theflexibility somewhat, and may be beneficial in some cases. It isrecommended to apply a steady flow of Ringer's solution through thetubing to electrode 14 during passage catheter through the vascularsystem to the electrode site, if possible. The flow of Ringer's solutionin this case assists in maintaining the patency of the lumen of tubing30, and prevents plugging of the exit ports of the electrode as it isadvanced into the cardiac muscle.

Surrounding tube 30 are two coils 32 and 34, which are wound in oppositedirections, to provide a torque cable. In the case of the specificdevices employed by the inventors, a torque cable as manufactured byLake Region Manufacturing Company of Chaska, Minn. employed, whichtorque cable is described in U.S. Pat. No. 5,165,421, incorporatedherein by reference in its entirety. Coils 32 and 34 also serve asconductors. As illustrated, tubing 30 is between metal coils 32 and 34and helical electrode 14. However, if polyimide tubing is used, thecoils 32 and 34 will serve as the only conductor and thus will beelectrically coupled to electrode 14 by means of welding, soldering ormechanical interconnection. Insulative sleeve 12 serves both to providea smooth exterior for the catheter and to insulate the metal coils 32and 34, along the length of the catheter.

FIGS. 3, 4 and 5 illustrate alternate embodiments of the helicalelectrode illustrated in FIG. 2. The electrode in FIG. 2 comprises ahollow tube having a single exit port located as its distal end.Electrode 36, illustrated in FIG. 3, corresponds to electrode 14 withthe exception that additional exit ports 38, 40 and 42 have been added,allowing for dispensing of the Ringer's solution along the length of thehelix. Ports 38, 40 and 42 may be laser drilled, and may be spaced inany desired fashion around the circumference of electrode 36 and alongthe length of electrode 36. Preferably, it is believed desirable to haveports spaced around the full circumference of the electrode, to providefor an even dispensing and dispersing of Ringer's solution.

Electrode 44, illustrated in FIG. 4 is a second alternative embodimentof a helical electrode corresponding to electrode 14, but with theaddition of an insulative sleeve 46, which covers the proximal portionof the electrode. Sleeve 46 limits the application of R-F energy to thedistal portion of the electrode. Optionally, additional exit portscorresponding to ports 38, 40 and 42 illustrated in FIG. 43 may also beemployed in conjunction with electrode 44. These additional exit portsmay be limited to the exposed, uninsulated portion of electrode 44, ormay extend along the entire length of electrode 44.

Electrode 48, illustrated in FIG. 5 is a third alternative embodimentcorresponding generally to electrode 14. However, in this case,electrode 48 is provided with a thermocouple 50 located in the distalend of electrode 48. Thermocouple wires 52 and 54 extend backwardsthrough the lumen within electrode 48 and are used to monitor thetemperature at the tip of the electrode, for use in feedback control ofpower applied to the electrode as described in the above-cited patentissued to Lennox et al. Only one of thermocouple wires 54 and 52 isinsulated, and the other is simply coupled to the interior of electrode48. In order to employ the electrode of FIG. 4B, an additionalelectrical connector would have to be added to the embodimentillustrated in FIG. 5, in order to allow connection to the thermocouplewire not connected to electrode 48. Alternatively, both thermocouplewires may be insulated, requiring two additional electrical connectorsat the proximal end of the device, each coupled to one of thethermocouple wires. It should be noted that the thermocouple 50effectively blocks the distal opening of the lumen within electrode 48,so that Ringer's solution will be dispensed only by means of side ports56, 58 and 60.

FIG. 6 illustrates a pressurized source for Ringer's solution which maybe employed in conjunction with catheter illustrated in FIG. 1. Areservoir 100 is provided, which is commercially manufactured by BlockMedical Inc., and sold under the brand name "Home Pump". The reservoircontains Ringer's solution and provides Ringer's solution at oneatmosphere pressure to flow control 102, via filter 104. Flow control102 may, for example, provide a flow limit of 20 drops or 1 cc perminute. Flow control 102 is coupled to a second flow control element104, which, in the experimental apparatus employed by the inventorsallows for additional adjustability of flow rates. Flow control 104 iscoupled to the luer lock 22, illustrated in FIG. 1, which in turn is influid communication with electrode 14 (FIG. 1), allowing delivery ofRinger's solution to the electrode. An electrosurgical generator 200 forproviding R-F electrical energy is illustrated in functional block form,coupled to electrical connector 24 and to a ground plate electrode 202(not drawn to scale). All other labeled elements correspond to thoseillustrated in FIG. 1.

Wile the embodiment illustrated above requires a second element (e.g. aguide catheter or guide wire) for advancing and positioning the catheterat its desired location, it is anticipated that the basic apparatusdisclosed above may also be incorporated into catheters which themselvesare steerable or deflectable, similar to R-F ablation catheterspresently in clinical investigation. Similarly, it is anticipated thatin commercial embodiments, alternative mechanisms (e.g. precision pumps)for controlling the flow of Ringer's solution may be employed.Similarly, while the inventors have employed Ringer's solution, otheralternative fluids may be workable as well. As such, the embodimentdiscussed above should be considered exemplary, rather than limiting, inconjunction with the following claims.

In conjunction with the above specification, we claim:
 1. A method ofcatheter ablation comprising:advancing a catheter having a proximal end,a distal end, an internal longitudinal lumen, an electrical conductor, ahollow needle mounted to said catheter body, an exterior surface of saidhollow needle comprising an electrode surface, said hollow needlecoupled to the internal lumen of said catheter and to said electricalconductor, to a desired site within a patient's body; inserting saidneedle into tissue at said desired site; delivering a saline solutionthrough the internal lumen of said catheter and said needle into saidtissue; coupling said electrical conductor to a source of electricalenergy; and only after initiation of delivery of said saline solutioninto said tissue, initiating delivery of electrical energy to saidelectrode surface to ablate said tissue, while said saline solutionremains present in said tissue.
 2. A method according to claim 1 furthercomprising the step of delivering said saline solution through theinternal lumen of said catheter and said needle into said tissue duringdelivery of electrical energy to said desired site.
 3. A methodaccording to claim 1 or claim 2 wherein said step of delivering salinesolution to said tissue prior to initiation of delivery of electricalenergy to said desired site comprises delivering said saline solutionfor at least two minutes prior to initiation of delivery of electricalenergy to said site.
 4. A method of catheter ablation,comprising:advancing a catheter having a proximal end, a distal end, aninternal longitudinal lumen, an electrical conductor, a hollow needlemounted to said catheter body, an exterior surface of said hollow needlecomprising an electrode surface, said hollow needle coupled to theinternal lumen of said catheter and to said electrical conductor, to adesired site within a patient's body; inserting said needle into saidtissue at said desired site; delivering a conductive fluid through theinternal lumen of said catheter and said needle and into said tissue;coupling said electrical conductor to a source of electrical energy; anddelivering electrical energy to said electrode surface to ablate saidtissue while said conductive fluid is present in said tissue, deliveryof said electrical energy initiated only after initiation of delivery ofsaid conductive fluid and continuing during delivery of said conductivefluid.
 5. A method according to claim 4, wherein said fluid deliveringstep comprises delivering said conductive fluid for at least two minutesprior to initiation of said delivery of said electrical energy.
 6. Amethod of catheter ablation, comprising:advancing a catheter having aproximal end, a distal end, an internal longitudinal lumen, anelectrical conductor, an electrode surface coupled to said conductor anda hollow needle mounted to said catheter body coupled to the internallumen of said catheter, to a desired site within a patient's body;inserting said needle into tissue at said desired site; applying aconductive fluid through the internal lumen of said catheter and saidneedle into said tissue; coupling said electrical conductor to a sourceof electrical energy; and only after initiation of application of saidconductive fluid into said tissue, initiating delivery of electricalenergy to said desired site by means of said electrode surface to ablatesaid tissue and continuing delivery of electrical energy to said desiredsite while said conductive fluid is being applied to said tissue.
 7. Amethod according to claim 6 wherein said fluid delivering step comprisesdelivering said conductive fluid for at least two minutes prior toinitiation of delivery of electrical energy.
 8. A method of catheterablation comprising:advancing a catheter having a proximal end, a distalend, an internal longitudinal lumen, an electrical conductor, anelectrode surface coupled to said conductor and a hollow needle mountedto said catheter body coupled to the internal lumen of said catheter, toa desired site within a patient's body; inserting said needle intotissue at said desired site; applying a saline solution through theinternal lumen of said catheter and said needle into said tissue;coupling said electrical conductor to a source of electrical energy; andonly after initiation of delivery of said saline solution into saidtissue, initiating delivery of electrical energy to said desired site bymeans of said electrode surface to ablate said tissue, while said salinesolution is present in said tissue.
 9. A method according to claim 8wherein said step of delivering electrical energy further comprisesdelivering electrical energy during delivery of said saline solutioninto said tissue.
 10. A method according to either claim 8 or 9 whereinsaid saline solution delivery step comprises delivering said salinesolution for at least two minutes prior to initiation of delivery ofsaid electrical energy.
 11. A method according to claims 1, 4, 6 or 8wherein said step of delivering electrical energy comprises deliveringR-F energy.
 12. A method of catheter ablation, comprising:advancing acatheter having a proximal end, a distal end, an internal longitudinallumen, an electrical conductor, an electrode surface coupled to saidconductor and a hollow helical needle mounted to said catheter body,coupled to the internal lumen of said catheter, to a desired site withina patient's body; screwing said hollow helical needle into said tissueat said desired site; coupling said electrical conductor to a source ofelectrical energy; and only after initiation of delivery of said salinesolution into said tissue, initiating delivery of electrical energy tosaid desired site by means of said electrode surface to ablate saidtissue, while said saline solution is present in said tissue.
 13. Amethod according to claim 12 wherein said step of delivering electricalenergy further comprises delivering electrical energy during delivery ofsaid saline solution into said tissue.
 14. A method according to claim12 or claim 13 wherein said saline solution delivery step comprisesdelivering said saline solution for at least two minutes prior toinitiation of delivery of said electrical energy.
 15. A method accordingto claim 12 wherein said step of delivering electrical energy comprisesdelivering RF energy.